Quality Assurance Associate — Batch Release & Compliance

Zvh; Sydney; On-site; AUD 70,000 - 100,000; Full time

Job summary

Baxter in Australia is seeking a motivated Quality Assurance Associate for our Toongabbie manufacturing site. You will help maintain the site's Quality Management System by ensuring batch documentation meets cGMP requirements, coordinating investigations of customer complaints, and supporting continuous improvement initiatives that enhance product quality and compliance.

Ideal candidates have a tertiary science or engineering degree and proven experience in sterile manufacturing or QA, with

Qualifications

• Bachelor's degree in Pharmacy, Science, Engineering or related field required.
• Experience in sterile manufacturing and/or QA processes preferred.
• Strong understanding of regulatory requirements and quality standards.
• Excellent attention to detail and analytical skills.

Responsibilities

• Review batch documentation for compliance prior to release to market.
• Investigate customer complaints and ensure timely closure per policy.
• Perform trend analysis of complaints and waste; drive improvements.
• Conduct root cause analyses for trends and deviations in MPI/NCRs.
• Ensure CAPAs are implemented and tracked in manufacturing processes.
• Support Monthly Indicators, Management Review, and Annual Product Review.
• Assist Release Department as needed.

Skills

Quality Assurance

Sterile Manufacturing

Regulatory compliance

Attention to detail

Communication

Time management

Education

Bachelor's degree in Pharmacy, Science, Engineering or related field

Tools

Quality Management Software

Job description

Baxter in Australia is seeking a motivated Quality Assurance Associate for our Toongabbie manufacturing site. You will help maintain the site's Quality Management System by ensuring batch documentation meets cGMP requirements, coordinating investigations of customer complaints, and supporting continuous improvement initiatives that enhance product quality and compliance.

Ideal candidates have a tertiary science or engineering degree and proven experience in sterile manufacturing or QA, with